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Completed Phase 2 Interventional Results available

Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

ClinicalTrials.gov ID: NCT03340675

Public ClinicalTrials.gov record NCT03340675. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and inevitably premature death of affected young men in their late twenties. DMD is the most common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every 3,500 live male births across all races and cultures, and results in 20,000 new cases each year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause of death. As there are yet no specific cardiac treatments to extend life, the current study aims to address this unmet medical need using a new therapeutic strategy for patients with DMD. Funding Source - FDA OOPD

Study identification

NCT ID
NCT03340675
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cumberland Pharmaceuticals
Industry
Enrollment
46 participants

Conditions and interventions

Eligibility (public fields only)

Age range
7 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 19, 2020 (Actual)
Primary completion
Mar 6, 2024 (Actual)
Completion
Jan 23, 2026 (Actual)
Last update posted
Mar 17, 2026

2020 – 2026

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Mattel Children's Hospital Los Angeles California 90095 —
Children's National Hospital Washington D.C. District of Columbia 20010 —
Children's Healthcare of Atlanta Atlanta Georgia 30341 —
Lurie Children's Hospital Chicago Illinois 60611 —
Riley Children's Hospital Indianapolis Indiana 46202 —
Kennedy Krieger Institute Baltimore Maryland 21205 —
Saint. Louis Children's Hospital St Louis Missouri 63110 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Monroe Carrell Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03340675, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 17, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03340675 live on ClinicalTrials.gov.

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